BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMUKIN-D

    MDR report key: 269397 · Received March 9, 2000

    Report

    Report Number
    8021034-1999-00002
    Event Type
    Other
    Date Received
    March 9, 2000
    Date of Event
    January 27, 1998
    Report Date
    January 28, 1998
    Manufacturer
    AMUCHINA S.P.A.
    Product Code
    LRJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A HIGH TEMPERATURE DURING HEMODIALYSIS. GRAM NEGATIVE BACTERIA WERE CULTURED FROM A SUBSEQUENT BLOOD SAMPLE.

    Description of Event or Problem · 2

    SECOND PT IN THE FACILITY HAD A HIGH TEMP DURING HEMODIALYSIS. GRAM-NEGATIVE BACTERIA WERE FOUND FROM A SUBSEQUENT BLOOD SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMUKIN-D DISINFECTANT FOR REPROCESSING LRJ AMUCHINA S.P.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other
    2 UNKNOWN Other